NA 389.202Recalls & reported problems
Synthes GmbH · LOW PROFILE PARALLEL DISTRACTOR · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034775036), received between Sep 20, 2021 and Sep 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2021Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PLIF METASTATIC TUMOR PROCEDURE, THE SUBTOTAL RESECTION WAS PERFORMED ON ONE SIDE OF L2. AFTER THE SYNCAGE-EX IMPLANT WAS INSERTED, THE SURGEON USED THE SPREADER TO RAISE THE IMPLANT WHEN A SMALL FRAGMENT OF THE SPREADER CAME OFF. THE FRAGMENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR (1) LOW PROFILE PARALLEL DISTRACTOR. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12496468 ↗
Other FORCEPS devices
- NA 314.291Synthes GmbH · FORCEPS177 reports
- NA 399.99Synthes GmbH · FORCEPS111 reports
- NA PDL114Synthes GmbH · FORCEPS81 reports
- GEM COUPLER Forceps GEM4183CSynovis Micro Companies Alliance, Inc · FORCEPS1 recall4 reports
- AESCULAP BJ025RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ058RAesculap AG · FORCEPS1 recall0 reports
- AESCULAP BJ062RAesculap AG · FORCEPS1 recall0 reports
- ATRAUMATA FB440RAesculap AG · FORCEPS1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page